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Comprehensive Rinse Studies

At Gateway Analytical, we understand that navigating rinse studies can be a maze of complexities. It’s not just about finding any lab, but one that truly understands the importance of getting every detail right for the sake of your product’s purity and safety. That’s where our team comes in, armed with comprehensive analytical expertise and a genuine commitment to ensuring your product reaches the highest quality standards of compliance and quality on your way to market.

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Gateway Analytical: Your Partner in Rinse Studies

Particulate bioburden is an all-to-often occurrence in pharmaceutical manufacturing. The advent of single-use systems and disposable products increased efficiency and eased the burden of laborious cleaning processes. However, this convenience gave rise to particulates entering the manufacturing process from these sources. We are here to assist you in designing a rinse study for both subvisible and visible particulates, ensuring that you obtain the necessary data and insights to choose the best consumables for your manufacturing. Don’t hesitate to contact us today to learn more!

Gateway Analytical - Analysis Solutions

Spotless Standards, Stellar Results

While the regulatory expectation remains that batches are essentially free of visible particulates, industry experts agree that ‘defect prevention’ is the best approach rather than relying on your visual inspection process to catch and reject contaminated units. To address this challenge, connect with Gateway Analytical for tailored solutions in minimizing particulate bioburden and enhancing product integrity.

Gateway Analytical - Analysis Solutions

Gateway Analytical Provides Clear Solutions for Complex Challenges

The number of requests for rinse studies rises each year at Gateway Analytical. And with each study, we take a holistic approach to customize the project to meet your needs. Our team has customized studies for companies with materials including:

  • 50–200L Bioprocessing Containers (BPC) & Bags
  • IV Infusion & Transfusion Sets
  • Bags of RTU/RTS Stoppers
  • Machine Components & Drums
  • Tubing & Catheter Sets

Early-Phase Development

Comprehensive packages designed to navigate clinical & regulatory complexities of parenteral product-package and container-closure development, from concept to market readiness.

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Container Closure
Integrity Testing

Quantitative, non-destructive, deterministic leak detection technologies for products stored in vials, syringes, cartridges, flexible containers, and bottles.

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Particulate
Analysis

Multi-analytical methods to count, size, and characterize visible and subvisible particulate matter in pharmaceuticals, disposable containers, single-use systems, raw materials, and medical devices.

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Medical Device
Analysis

Rigorous studies focused on enumerating particulate matter and identifying potential chemical compounds that could migrate from medical devices into the environment or directly impact patient health.

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Extractables
& Leachables

Studies aimed at identifying potentially harmful compounds in manufacturing components and final containers to ensure the safety and efficacy of pharmaceutical products.

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